Laval, July 13, 2009
Roche Diagnostics Distributes TheraScreen®: K-RAS Mutation Kit
Test aids physicians to identify colorectal cancer patients who are unlikely to benefit from certain cancer drugs based on their genetic mutations
Roche Diagnostics announced today that it has begun the exclusive distribution of the TheraScreen®: K-RAS Mutation Kit in Canada, following approval of the test kit by Health Canada. The TheraScreen®: K-RAS Mutation Kit, manufactured by UK-based DxS Ltd, is intended to provide doctors with information that may guide them in making subsequent therapeutic decisions for their colorectal cancer patients who may not benefit from anti-EGFR therapy such as cetuximab or panitumumab.
Colorectal cancer is the third most common cancer and the second leading cause of cancer death in the world. This year an estimated 22,000 Canadians (12,100 men - 9,900 women) will be diagnosed with colorectal cancer and approximately 9,100 (4,900 men - 4,200 women) will die from it. (1)
Recent studies have shown that efficacy of anti-EGFR monoclonal therapies such as panitumumab and cetuximab is limited to patients with wild-type K-RAS. The K-RAS Mutation Kit identifies those colorectal cancer patients who have a mutation in their K-RAS gene (approximately 35 to 45 percent) and who will therefore not derive benefit from anti-EGFR therapies.
The TheraScreen®: K-RAS Mutation Kit detects not only low level mutations that may be missed by sequencing methods, but can also deliver qualitative and accurate detection of the seven mutations in the K-RAS gene that account for more than 96% of all mutations. The test is highly sensitive and can detect as little as 1% mutation in a background of wild-type genomic DNA.
“The use of diagnostic tests such as the TheraScreen®: K-RAS Mutation Kit provides information to oncologists allowing them to better target treatment to the individual patient,” said Christopher Parker, President and General Manager of Roche Diagnostics Canada. “Being able to more clearly identify which patients will not benefit from a particular drug has the potential to improve overall treatment outcomes and reduce the costs associated with cancer therapy,” he concluded.
DxS is a UK-based personalized medicine company providing molecular diagnostics to aid doctors and drug companies in selecting therapies for patients. DxS offers products, technology and services to the healthcare industry to enable the delivery of safe and effective medicines. Working predominantly in the field of cancer, DxS has a range of companion diagnostic and research kits that detect mutations in oncogenes associated with cancer drug response. The TheraScreen® range of CE Mark certified diagnostic products includes kits that detect mutations in the EGFR and K-RAS genes. Tumor mutation products are available for research use for EGFR, RAS, RAF, BCR-ABL and other genes that show a correlation between patient mutation status and drug response. DxS also provides a genetic analysis service to support clinical development. For more information, visit www.dxsdiagnostics.com.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.
In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. Additional information is available on the Internet at www.roche.com and www.rochediagnostics.ca.
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(1) Colorectal Cancer Association of Canada website http://www.colorectal-cancer.ca/en/just-the-facts/colorectal/